The US Food and Drug Administration (FDA) has approved Genzyme's manufacturing plant in Framingham, Massachusetts, for the production of Fabrazyme (agalsidase beta). This follows the previously announced approval by the European Medicines Agency (EMA) last week.
“We are very pleased with the FDA approval of our Framingham plant as we continue our manufacturing recovery and path forward to serve the Fabry patient community,” said Genzyme’s president and CEO David Meeker. “With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”
Approval of the Framingham site allows Genzyme to begin the process of returning patients to full dosing (1 mg/kg) levels. Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in Q1 2012. Beginning in March, all patients in the US currently on therapy will be returned to full dosing. In addition, the company will begin to transition new patients in the US onto Fabrazyme, at full dosing levels. Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned, as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases and focussed on rare diseases and multiple sclerosis, dedicated to making a positive impact on the lives of the patients and families